Omega 3 Fatty Acid Efficiency for Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting

This study has suspended participant recruitment.
(Interim analysis)
Sponsor:
Information provided by (Responsible Party):
Efremov Sergey, Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT01175330
First received: August 3, 2010
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to evaluate efficacy of Polyunsaturated Fatty Acid for the prevention of Atrial Fibrillation and anti-inflammatory effects in patients after CABG surgery


Condition Intervention Phase
Ischemic Heart Disease
Atrial Fibrillation
Drug: Omega-3 fish oil emulsion (Omegaven)
Drug: Intralipid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

Primary Outcome Measures:
  • Freedom of Atrial Fibrillation or other atrial arrhythmias [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: August 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: CABG and intralipid infusion
Procedure: CABG surgery and subcutaneous cardiac monitor implantation Drug: Intralipid Lipid emulsion (Intralipid) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period)
Drug: Intralipid
Lipid emulsion (Intralipid) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period)
Active Comparator: CABG and omega-3 fatty acid infusion
Procedure: CABG surgery and subcutaneous cardiac monitor implantation Drug: Omegaven Lipid emulsion (omegaven) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period)
Drug: Omega-3 fish oil emulsion (Omegaven)
Lipid emulsion (omegaven) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective CABG surgery.
  • Signed, documented informed consent prior to admission to the study.

Exclusion Criteria:

  • Unstable angina, requiring intervention or CABG <24 hrs after screening.
  • Decompensated congestive heart failure.
  • Chronic, persistent, paroxysmal atrial fibrillation.
  • Uncorrected significant valvular heart disease
  • Known hypersensitivity to the study drug
  • Left ventricular dysfunction (ejection fraction <35%)
  • Use of anti-arrhythmic drugs other than beta blockers
  • Non-cardiac illness with a life expectancy of less than 1 year
  • Bleeding diathesis or history of coagulopathy
  • Significant renal and liver insufficiency
  • Significant thyroid, pulmonary disease
  • Uncontrolled diabetes mellitus
  • Patients on anti-arrhythmic drugs
  • Patients with pacemaker
  • Patients unable to provide/sign informed consent.
  • Patients currently taking marine based omega-three fish oil supplements.
  • Disturbances in lipid metabolism, serum triglyceride value >3 mmol/l
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175330

Locations
Russian Federation
State Research Institute of Circulation Patholody
Novosibirsk, Russian Federation, 630055
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
  More Information

No publications provided

Responsible Party: Efremov Sergey, Anesthesist, Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01175330     History of Changes
Other Study ID Numbers: FAFPAF-042, MCAFS-042
Study First Received: August 3, 2010
Last Updated: December 19, 2012
Health Authority: Russia: Ethics Committee

Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Omega-3 fatty acid
Ischemic Heart Disease
Atrial Fibrillation
Subcutaneous cardiac monitoring

Additional relevant MeSH terms:
Heart Diseases
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014